JP7090165B2 - Atherectomy system - Google Patents

Description

The present disclosure relates to medical devices, as well as methods for manufacturing and using medical devices. More specifically, the present disclosure relates to rotating medical devices, methods, and systems, including those equipped with electric motors.

A variety of medical devices have been developed for medical use, for example, for use in entering the body cavity and interacting with fluids and structures within the body cavity. Some of these devices include guide wires, catheters, pumps, motors, controls, filters, grinders, needles, valves, and delivery devices, and / or systems used to deliver such devices. Can include. These devices are manufactured by any one of a variety of different manufacturing methods and can be used according to any one of the various methods. Each of the known medical devices and methods has certain advantages and disadvantages.

The present disclosure provides alternative designs, materials, manufacturing methods, and uses for medical devices and systems. In a first aspect, the medical device is configured to rotate a drive shaft, a rotary tip coupled to a first end of the drive shaft, and a second end of the drive shaft to rotate the rotary tip. The motor may be provided with a control unit configured to control the load output from the motor, the control unit configured to set the maximum load output from the motor after the first rotation of the motor. obtain.

As an addition or alternative, and in the second aspect, the control unit determines the load output from the motor after the first rotation of the motor and from the motor based on the determined load output from the motor. It is configured to set the maximum load output.

As an addition or alternative, and in a third aspect, the control unit has a predetermined range of acceptable load output from the motor, and the control unit is based on the determined load output from the motor. The allowable load output in the predetermined range is shifted to set the maximum load output from the motor.

As an addition or alternative, and in a fourth aspect, the control unit is configured to set the maximum load output from the motor to a predetermined value that is greater than the determined load output from the motor. Will be done.

As an addition or alternative, and in a fifth aspect, the control unit compares the determined load output from the motor to a threshold and if the determined load output from the motor reaches or exceeds the threshold. Sets the reference load output from the motor to the threshold value, and if the determined load output from the motor does not reach the threshold value, sets the reference load output from the motor to the determined motor. The load output is set, and the maximum load output from the motor is set based on the reference load output from the motor.

As an addition or alternative, and in the sixth aspect, the control unit sets the reference load output from the motor to zero and sets the maximum load output from the motor based on the reference load output from the motor. It is configured to be set.

As an addition or alternative, and in a seventh aspect, the control unit is configured to set the maximum load output from the motor to a predetermined level greater than zero.
As an addition or alternative, and in an eighth aspect, the control unit is configured to set the reference load output from the motor to zero when the button is activated.

As an addition or alternative, and in a ninth aspect, the control unit is configured to automatically set the reference load output from the motor to zero at a predetermined timing after the first rotation of the motor. ing.

As an addition or alternative, and in a tenth aspect, the medical device further comprises a button, the control unit being configured to set the maximum load output from the motor when the button is activated.

As an addition or alternative, and in the eleventh aspect, the control unit is configured to automatically set the maximum load output from the motor at a predetermined timing after the first rotation of the motor. ..

As an addition or alternative, and in a twelfth aspect, the medical device further comprises a button, the control unit sets the maximum load output from the motor for the first time after the first rotation of the motor, and the button is activated. In response to, the maximum load output from the motor is set for the second time after the first rotation of the motor.

As an addition or alternative, and in the thirteenth aspect, the method of controlling the medical device is to determine the load output from the motor of the medical device after the start of the motor and to determine the predetermined load output amount. It is configured to set the maximum load output from the motor based on the load output from the motor and to establish the load output from the motor that is less than the set maximum load output from the motor. It includes determining a control signal of the motor and outputting the control signal to keep the load output from the motor lower than the set maximum load output from the motor.

As an addition or alternative, and in a fourteenth aspect, the method further comprises comparing the determined load output from the motor with a threshold reference load output from the motor, said said motor. If the load output from the motor does not reach or exceed the threshold reference load output from the motor, the maximum load output from the motor is a value based on the predetermined load output amount and the determined load output from the motor. When the determined load output from the motor reaches or exceeds the threshold reference load output from the motor, the maximum load output from the motor is set to the predetermined load output amount and the threshold value from the motor. Set to a value based on the reference load output.

As an addition or alternative, and in a fifteenth aspect, the method further comprises setting a reference load output from the motor based on the determined load output from the motor, the set motor. The maximum load output from is based on the predetermined load output amount and the set reference load output from the motor.

As an additional or alternative, and in the sixteenth aspect, if the determined load output from the motor does not reach or exceed the threshold reference load output from the motor, the reference load output from the motor is Set to zero.

As an addition or alternative, and in the seventeenth aspect, the control unit of the medical device may include a processing unit and a memory that communicates with the processing unit, which determines the load output from the motor of the medical device. The maximum load output from the motor is set based on the determined load output from the motor, the set maximum load output from the motor is stored in the memory, and the maximum load output from the set motor is smaller than the set maximum load output. A control signal configured to achieve the load output from the motor is output to the motor.

As an addition or alternative, and in an eighteenth aspect, the processing unit is configured to compare the determined load output from the motor with the threshold reference load output from the motor, said said. When the load output from the motor does not reach or exceed the threshold reference load output from the motor, the maximum load output from the motor is the predetermined load output amount and the determined load output from the motor. When the value is set based on the value and the determined load output from the motor reaches or exceeds the threshold reference load output from the motor, the maximum load output from the motor is obtained from the predetermined load output amount and the motor. Set to a value based on the reference load output of.

As an addition or alternative, and in the nineteenth aspect, the control unit may be configured to set the maximum load output from the motor in response to the activation of the tare button.
As an addition or alternative, and in a twentieth aspect, the control unit is configured to automatically set the maximum load output from the motor at a predetermined timing after the first rotation of the motor. ..

Various modifications and alternatives are possible in this disclosure, the details of which are shown as examples in the drawings and are described in detail. However, it should be understood that the embodiments of the present disclosure are not intended to be limited to the particular exemplary embodiments described herein. Rather, it is intended to cover all changes, equivalents, and alternatives contained within the spirit and scope of this disclosure.

The present disclosure may be more fully understood in connection with the accompanying drawings, taking into account the following description of various exemplary embodiments of the present disclosure.
It is a schematic diagram of an exemplary atherectomy system. It is a schematic box diagram of an exemplary atherectomy system. It is a schematic flow diagram of an exemplary atherectomy system. It is a schematic side view of the part of an exemplary atherectomy system in a linear configuration. FIG. 3 is a schematic side view of a portion of an exemplary atherectomy system in a curved configuration. It is a graph which shows the 1st range and the 2nd range of the load output from a motor without complement which considered the reference load output from a motor. It is a graph which shows the 1st range and the 2nd range of the load output from a motor which was complemented in consideration of the reference load output from a motor. It is a schematic flow chart of the exemplary operation method of an atherectomy system. It is a schematic flow chart of the exemplary operation method of an atherectomy system.

Various modifications and alternatives are possible in the present disclosure, the details of which are shown by way of illustration in the drawings and are described in detail. However, it should be understood that the embodiments of the present disclosure are not intended to be limited to the particular exemplary embodiments described herein. Rather, it is intended to cover all modifications, equivalents, and alternatives contained within the spirit and scope of this disclosure.

The following defined terms shall apply, unless different definitions are given in the claims or elsewhere herein.
As used herein, all numbers are assumed to be modified by the term "about", whether explicitly stated or not. The term "about" generally refers to a range of numbers that one of ordinary skill in the art would consider equivalent to the listed values (eg, with the same function or result). In many cases, the term "about" may include a number rounded to the nearest significant digit.

The list of numerical ranges by termination value includes all numbers within that range (eg, 1 to 5 are 1, 1.5, 2, 2.75, 3, 3.80, 4, and). 5 is included).
As used herein and in the appended claims, the singular forms "a", "an", and "the" include a plurality of referents unless the content clearly dictates otherwise. As used herein and in the appended claims, the term "or" is commonly used in the sense to include "and / or" unless the content explicitly indicates otherwise.

References herein to "one embodiment," "some embodiments," "other embodiments," and / or other similar terms are specific to one or more embodiments described. Note that it may include features, structures, and / or properties. However, such enumeration does not necessarily mean that all embodiments contain specific features, structures, and / or properties. Further, where a particular feature, structure, and / or property is described in connection with an embodiment, such feature, structure, and / or property is explicitly described unless explicitly stated in the opposite direction. It should be understood that it may be used in connection with other embodiments, whether or not it has been used.

The detailed description below should be read with reference to the drawings as similar elements in different drawings are numbered the same. The drawings, which are not necessarily in scale, show exemplary embodiments and are not intended to limit the scope of the invention.

Cardiovascular and peripheral arterial disease result from the accumulation of atherosclerosis on the inner walls of the lumen of blood vessels, causing a condition known as atherosclerosis. Atherosclerotic and other vascular deposits restrict blood flow, the patient's heart, the patient's limb vasculature (eg, legs, arms, head, etc.), the patient's carotid artery, and / or the patient's other vasculature. Can cause ischemia. Such ischemia can cause pain, swelling, irreparable wounds, amputations, strokes, myocardial infarctions, and / or other conditions.

Atherosclerotic deposits have widely variable properties, some deposits are relatively soft, others are fibrous and / or calcified. In the latter case, the deposits are sometimes called plaques. Atherosclerosis occurs spontaneously as a result of aging, but can be exacerbated by factors such as diet, hypertension, heredity, and vascular damage. Atherosclerosis can be treated in a variety of ways, including drugs, bypass surgery, and various catheter-based approaches that rely on the removal of intravascular dilation or atherosclerosis or other substances that occlude blood vessels. Atherectomy is a catheter-based treatment that can be used to treat atherosclerosis.

Atherectomy is an interventional procedure performed to restore blood flow through a portion of the patient's vascular system that has been blocked by plaque or other substance (eg, blocked by obstruction). Atherectomy procedures use a device at the end of the drive shaft to engage with plaques and other substances and remove those substances from the patient's blood vessels (such as arteries and veins) (eg, polishing, polishing, cutting). , Shaving, etc.). In some cases, the device at the end of the drive shaft is either abrasive or when the device rotates and engages with plaque or other obstacles, plaque from the vessel wall or other obstacles within the vessel. Is configured to remove.

FIG. 1 shows an atherectomy system 10. The atherectomy system 10 may be electrically driven, pneumatically driven, and / or driven in one or more other suitable embodiments. Additional or alternative components to those illustrated and described herein may be utilized in the operation of the atherectomy system 10.

The atherectomy system 10 may include a drive assembly 12 and a control unit 14 (eg, a control unit). Although the control unit 14 is shown in FIG. 1 as being separated from the drive assembly 12, the functions of the control unit 14 and the drive assembly 12 may be integrated into a single component.

The drive assembly 12, among other elements, is an advanced assembly 16, a drive shaft 18 (eg, a flexible drive shaft or other drive shaft), a rotating device 20 (eg, a rotating tip or other rotating device), and a first. A length with a lumen extending from one end (eg, a proximal end), a second end (eg, a distal end), and a first end to a second end for receiving a drive shaft 18. The scale member 22 may be included. In some cases, the elongated member 22 may be an elongated tubular member. The rotating device 20 may have a rough or sharp surface such that when rotated, the plaque can be constructed to be able to grind, polish, cut and shave plaque from the vessel wall or other obstacles within the vessel.

The advanced assembly 16 may include an advanced knob 23 that includes a motor (eg, an electric motor, a pneumatic motor, or other suitable motor) that communicates with the advanced knob 23, a drive shaft 18, and a control unit 14 in the advanced assembly housing. It can be accommodated in 26. The advance knob 23 may be configured to advance along a longitudinal path to advance the motor and rotating device 20 longitudinally. The motor includes, but is not limited to, welded connections, clamped connections, adhesives, threaded connections, and / or other suitable connections configured to withstand high speeds and forces. Can be combined with. Since the drive shaft 18 can rotate over a wide range of speeds (eg, at speeds from zero (0) RPM to 250,000 RPM and above), the coupling between the motor and the drive shaft 18 is such a rotational speed and association. Can be configured to withstand the force of

The drive shaft 18 can be made of one or more different materials. For example, the drive shaft 18 may be made of one or more different materials, including iron, stainless steel, and / or other suitable materials.

The drive shaft 18 may have an appropriate diameter and / or length for traversing the patient's vascular structure. In some cases, the drive shaft 18 can have a diameter in the range of about 0.030 cm (cm) or less to about 0.150 cm or more, and a working length in the range of about 10 cm or less to about 300 cm. In one example, the drive shaft 18 may have a diameter of about 0.05715 cm and a length of about 50 cm. Alternatively, the drive shaft 18 may have different suitable diameters and / or different suitable lengths.

The rotating device 20 may have an outer circumference equal to or larger than the distal diameter of the drive shaft 18 and / or the elongated member 22. Alternatively or additionally, the rotating device 20 may have an outer circumference smaller than the diameter of the drive shaft 18 and / or the elongated member 22. The rotating device 20 can have a symmetric design to penetrate equally well in both directions, but this is not required and the rotating device 20 may be configured to penetrate in only one direction. .. The diameter of the drive shaft 18 may depend on the lumen dimensions of the elongated member 22 and / or one or more other factors.

The rotating device 20 may be coupled to the drive shaft 18. If the drive shaft 18 has a first end (eg, a proximal end) and a second end (eg, a distal end), the rotating device 20 will have the drive shaft 18 at or near the second end. Can be combined with. In some cases, the rotating device 20 may be located at or near the end of the second end of the drive shaft 18.

The rotating device 20 may be coupled to the drive shaft 18 in any embodiment. For example, the rotating device 20 may be coupled to the drive shaft 18 with an adhesive, threaded connection, welded connection, clamped connection, and / or other suitable connection configured to withstand high rotational speeds and high rotational forces. Similar to those described above with respect to the connection between the drive shaft 18 and the motor, the drive shaft 18 and / or the rotating device 20 can rotate at speeds between zero (0) RPM and 250,000 RPM and above, thus driving. The shaft 18 and the rotating device 20 may be configured to withstand such rotational speeds and associated forces.

The drive assembly 12 and the control unit 14 may be communicative, may be located in the same housing, may have the same housing, and / or may have separate housings (eg, the advanced assembly housing 26 and the control). It may be located in the unit housing 28 or other housing) or may have a separate housing. The drive assembly 12 and the control unit 14, whether in the same housing or in separate housings, communicate via a wired connection (eg, via one or more wires of the electrical connector 24) and / or a wireless connection. obtain. Wireless connections include mobile communications, ZigBee®, Bluetooth®, WiFi®, IrDA, Dedicated Short Range Communications (DSRC), EnOcean®, and / or other suitable general. It is done via one or more desired communication protocols, including but not limited to target or proprietary wireless protocols.

In some cases, the drive assembly 12 may include one or more control buttons configured to perform and control the operation of the motors of the drive assembly 12. In one example, the drive assembly may include a button 27 configured to initiate the setting or establishment of maximum load output from the motor. As shown in FIG. 1, the button 27 may be located on the housing 26 of the advanced assembly 16, which, if necessary, communicates with electronic components configured to control the operation of the motor. It can be placed in one or more other locations. The button 27 can be a physical button and / or a virtual button that can be selected via the touch sensitive surface. The drive assembly 12 may include one or more buttons or other selectable components in addition to or as an alternative to the button 27.

Although not necessarily shown in FIG. 1, the drive assembly 12 may include and / or contain one or more operating features. For example, among other things, the drive assembly 12 may include a motor, control buttons, control knobs configured to advance the rotating device 20, rubber feet, control electronics, drive circuits and the like.

The control unit 14, which may be separated from the drive assembly 12 (eg, as shown in FIG. 1) or may be included in the drive assembly 12, may include several features. For example, as shown in FIG. 1, the control unit 14 may include a display 30 and a control knob 32 (eg, a motor speed (eg RPM or other speed) adjustment knob or other control knob). Additional or alternative, the control unit 14 has one or more other features for controlling the motor and / or processing unit, memory, input / output device, speaker, volume control button, on / off power switch, It may include other features of the drive assembly 12 including, but not limited to, motor start switches, timers, clocks, and / or other functions (eg, one or more motor states of the motor).

In some cases, the control unit 14 may include one or more motor load output control mechanisms for controlling the operation of the atherectomy system 10. In an example of a motor load output control mechanism that may be included in the control unit 14, the control unit 14 is the maximum load from the motor based on the load output of the motor determined after the initial start-up (eg, first rotation) of the motor. It may include a mechanism configured to set and / or adjust the output. Additional or alternative, the control unit 14 may include other control and / or safety mechanisms to control the operation of the atherectomy system 10 and reduce the risk to the patient.

FIG. 2 shows a block diagram of the atherectomy system 10. The atelectomy system 10 includes a drive circuit 36 (optionally included), a motor 37 communicating with the drive circuit 36 (eg, an electric motor, a turbine, or other suitable drive mechanism), motor parameters (eg, drive current, drive). Continuous rotation with the motor 37 via a sensor for sensing voltage, motor position, etc. (eg, first sensor 44, second sensor 46, and / or other suitable sensor), and drive shaft 18. The device 20 may be included. The drive shaft 18 is shown as a spring in FIGS. 2 and 3 because torque can accumulate on the drive shaft 18.

When the drive circuit 36 is included in the atherectomy system 10, the drive circuit 36 may be mounted on a board or other component within the advanced assembly housing 26 of the drive assembly 12 and may electrically communicate with the control unit 14. The drive circuit 36 can include, but does not necessarily have to, include a microprocessor and / or a microcontroller, an application-specific integrated circuit (“ASIC”), and / or an application-specific standard product (36 “ASSP”). .. In some cases, the drive circuit 36 may (at least partially) be incorporated into the control unit 14, but this is not required.

As mentioned above, the atherectomy system 10 may include one or more features configured to facilitate control of the operation of the drive assembly 12. As shown in FIG. 2, the atelectomy system 10 includes, among other things (eg, to the control unit 14 or drive assembly 12), a button 27, a processor 38 (eg, a microprocessor, a microcontroller, etc.), a memory 40, a display 30, etc. It may include one or more other suitable components for controlling the operation of the input / output port 42 and / or the drive assembly 12.

The processing unit 38 may be operably coupled to the memory 40. The memory 40 is used to store any desired information such as control algorithms, set points, plans, control plans, time, eg, diagnostic limits such as speed limits, RPM limits, torque limits, current limits, voltage limits, etc. Can be done. The processing unit 38 may be configured to access the information stored in the memory 40 to facilitate the operation of the atherectomy system 10. The memory 40 may include any one or more suitable types of storage devices including, but not limited to, RAM, ROM, EPROM, flash memory, hard drives and the like. In some cases, the processing unit 38 can store information in memory 40 and then retrieve the stored information from memory 40 to perform and / or analyze the operation of the atherectomy device. .. Further, the processing unit 38 and / or the memory 40 may include a timer (not shown) and / or may communicate with the timer.

The input / output port 42 may be configured to receive input from one or more components of the atherectomy system 10. In one example, the input / output port 42 receives input from a button 27, a drive circuit 36, a first sensor 44, a second sensor 46, and / or one or more other components of the teletomy system 10. Output can be provided for and / or these.

FIG. 3 shows a schematic block diagram of the control software and circuit of the atherectomy system 10 coupled to the motor 37, which is operably attached to the drive shaft 18 and the rotating device 20. Control software and circuits include, among other things, drive circuit 36 (if included), control planning element 48, motor state estimation unit 50 (eg, motor state observer or other motor state estimation unit), and control unit 52 (eg, feedback). It may include a controller, a closed loop controller, and / or a feedback regulator such as a proportional integral derivative (PID) controller or other controller). The control planning element 48, the motor state estimation unit 50, and the control unit 52 are shown as separate components in FIG. 3, but one of the control planning element 48, the motor state estimation unit 50, and the control unit 52. One or more may be a single control unit or processing unit, or a plurality of control units or processing units that may be configured to perform the functions of the disclosed control planning element 48, motor state estimation unit 50, and control unit 52. Can be implemented in. Although not necessarily required, one or more of the control planning element 48, the motor state estimation unit 50, the control unit 52, the drive circuit 36, and / or the other electronic processing components of the teletomy system 10 may be the processing unit 38, It can be mounted in memory 40 and / or input / output port 42 (eg, processing unit 38, memory 40, and / or input / output port 42 are control planning element 48, motor state estimation unit 50, control unit 52, drive. (Performs the operation of the circuit 36 and / or the other electronic processing components of the atelectomy system 10).

The control design element 48 may include a control plan that associates the motor state with a motor input or a set point of the motor state (eg, a reference value). That is, for any possible value of the motor state, the control plan may have a relevant reference value (eg, a motor input or a set point of the motor state). Exemplary motor states may include, but are not limited to, motor speed, motor position, motor torque, motor drive current, motor drive voltage, motor drive power, and / or other motor states. An exemplary control scheme can relate speed to torque, speed to current, speed to voltage, and / or one or more other motor states to a reference motor state. For example, a control system that utilizes a control scheme that associates speed with torque receives a speed input (eg, from the motor state estimator 50 or other component of the teletomy system 10) and the reference torque (eg, from which the control signal would be based). For example, for use of the control unit 52 or other components of the teletomy system 10). The control planning element 48 can be used to determine the control signal, while the control unit 52 utilizes one or more known control techniques based on feedback from the motor state estimation unit 50 and / or other feedback information. It is contemplated that the control signal can be determined without using the control design element 48.

In some cases, the control plan of control plan element 48 is stored in memory 40 and / or other memory and is accessed or otherwise utilized by processing unit 38 for input (eg, input motor state, speed). Etc.) to determine the reference value. The control planning element 48 can be, but may be, memory 40 or include memory 40, although it is not essential.

The control plan may be pre-determined prior to the operation of the atherectomy device (eg, during calibration or preset by the manufacturer) and may be stored in memory 40 or other memory. In some cases, the user may be able to adjust or modify the control plan and store it in memory 40 or other memory to establish a given or offline control plan. The control plan can be considered predetermined or offline if it does not change in real time during the operation of the drive assembly 12.

In some cases, the control design element 48 may include a predetermined range of load output from the motor 37 for passing the occlusion in the patient's blood vessels. A predetermined range of load outputs may include a maximum load output from the motor 37 based on one or more factors. For example, the maximum load output can be based on the expected level of load transfer to the rotating device 20 when no external load is acting on the drive shaft 18, rotating device 20, and / or elongated member 22. .. The external load can be caused by the rotating device 20, which is engaged in the occlusion of the patient's blood vessels, is bent at the elongated member 22, is bent at the drive shaft 18, and / or the procedure (eg, atherectomy). It can be caused by other loads acting on the drive shaft 18, the rotating device 20, and / or the elongated member 22 during the procedure or other suitable procedure). As discussed in more detail below, the control unit 52 determines the load output from the motor in response to one or more external loads acting on the drive shaft 18, the rotating device 20, and / or the elongated member 22. It may be configured to adjust at least a portion of the range (eg, shift or adjust in one or more other suitable ways). In some cases, the control unit 52 can store the adjusted load output in the predetermined range output from the motor 37 in the memory 40.

The motor state estimation unit 50 estimates one or more states of the motor 37 based on the input received from the sensor that senses the motor parameters (eg, the sensed motor parameters can be the measured motor states). Can be configured as Examples of motor parameters include drive current, drive voltage, input power, motor position, and the like. In one example, the first sensor 44 can sense the input current to the motor 37 and provide the motor state estimation unit 50 with a signal indicating the value of the motor drive current or other electrical input. Additional or alternative, the second sensor 46 may sense the position of the motor 37 and provide a signal indicating the position value of the motor 37 to the motor state estimation unit 50. In some cases, the sensor configured to sense the position of the motor may be a Hall effect sensor, but other position sensors may be used in addition or alternatives. Although sensors 44, 46 are disclosed as sensing current and motor position, these sensors can be configured to sense additional or alternative other parameters and / or similar or different motors. Other sensors that sense the parameters may be included in the telectomy system 10.

The motor state estimation unit 50 can calculate (eg, estimate) one or more motor states based on the sensed values of the motor parameters provided to the motor state estimation unit 50. In one example, the motor state estimator 50 determines the speed of the motor 37 (eg RPM or other speed parameter) based on the received value indicating the motor position, the timing of the position values, and the known relationship between the motor position and time. It can be calculated or determined (eg, estimated). In another example, the motor state estimator 50 of the motor 37 is based on a received value indicating the motor position, a received value indicating the drive current or other electrical input, and a known relationship between the motor position and the electrical input to the motor. Calculate or determine (eg, estimate) torque (eg, load output). Additional or alternative, other motor states may be determined by the motor state estimation unit 50.

The control unit 52 or other control unit may be configured to provide control signals to the drive circuit 36 (if included) and / or the motor 37. In some cases, the control unit 52 or other control unit may receive control values based on the motor parameters from the control planning element 48 and the current values of the motor state calculated or determined from the motor state estimation unit 50. .. In one example, the control value received from the control design element is the control load output and may be within a predetermined range of the load output. Based on calculating or comparing the control value with the determined value, the control unit 52 or another control unit may determine a control signal for maintaining or adjusting the operation of the motor 37. In some cases, when a large delta occurs between the control value and the calculated or determined value, or when a threshold is reached, the control unit 52 supplies the motor 37 to actively brake (eg, feed the motor 37). (Reverse the direction of the current to be applied or the direction of the torque of the motor 37), the signal can be transmitted to the drive circuit 36 and / or the motor 37. In some cases, the motor can be actively braked until rotation stops. Utilizes a control unit in addition to or other than the control unit 52 configured to determine the motor control signal based on the control value of the parameter compared to the measured, determined, or calculated real-time value of the parameter. be able to. Alternatively or additionally, the control unit 52 or other control unit determines the control signal of the motor by one or more other suitable methods and the load output from the motor is within a predetermined range of the motor. The load output can be maintained.

A control planning element 48, a motor state estimation unit 50, and a control unit 52 or other having a functionally similar configuration, along with feedback from the first sensor 44, the second sensor 46, and / or other sensors. The system may facilitate closed-loop control of the motor 37 and the rotating device 20 based on feedback from sensors (eg, first sensor 44 and second sensor 46) and control planning of control planning element 48. This closed loop control of the motor 37 and the rotating device 20 can facilitate keeping the load output from the motor within a predetermined range of the load output from the motor, and the predetermined range of the load output from the motor The appropriate load output at the rotating device 20 is configured to allow it to rise to a safety limit that facilitates passage through the occlusion without injuring the patient.

In some cases, the control unit 52 or other control unit is the first estimation from the motor at the start of the motor and / or after the first rotation of the motor 37 (eg, the first operation of the motor 37 at the start). It may be configured to adjust the range of predetermined load output from the motor 37 based on the value or the determined load output from the motor. For example, at a predetermined time after the first start or first rotation of the motor 37, and / or in response to the selection of the button 27, the control unit 52 or another control unit may output a load output from the motor 37 (eg, for example). , The first load output from the motor 37 or another load output) and set the reference load output from the motor based on the determined initial load output from the motor 37. Next, the control unit 52 or other to take into account the external load acting between the motor 37 and the rotating device 20 and / or the motor 37 and the rotating device 20 based on the reference load output from the motor 37. The control unit may adjust (eg, shift, expand, or decrease) a range of predetermined load outputs from the motor 37. In some cases, the end point of the range of predetermined load output from the motor 37 is shifted, the range of the predetermined load output from the motor 37 is expanded, and / or the range of the predetermined load output from the motor 37 is shifted. That may include setting or adjusting the maximum load output from the motor 37 based on the reference load output from the motor 37.

4 and 5 show the components of the atherectomy system 10 extending over the guide wire 25 (eg, drive shaft 18, rotating device 20, long member 22, and motor 37), and FIG. 4 shows a linear configuration. The components are shown, and FIG. 5 shows the components of the curved configuration. FIG. 5 can represent a winding path through the patient's blood vessels, which can occur when the rotating device 20 and / or the drive shaft 18 is delivered to a location adjacent to the obstruction of the patient's blood vessels.

When the component of the atherectomy system 10 shown in FIG. 4 is rotated, the external load acting on the component due to the bending of the component is applied to the external load acting on the component of the atherectomy system 10 shown in FIG. On the other hand, it will be relatively small. Thus, a predetermined range of load output from the motor 37 can be determined when the components of the atherectomy system 10 are in a configuration similar to that shown in FIG. 4 (eg, the atherectomy system 10 is used in the procedure). Determined before). The maximum load output of the load output from the motor 37 in a predetermined range of the load output from the motor 37 may be configured to provide a "safety limit" of torque (eg, output load) on the patient's rotating device 20.

As shown in FIG. 5, the components of the atherectomy system 10 have one or more bends or bends (eg, first bend 54 and second bend 56 of the other bends). Can be. Such bends can occur when following the winding pathways of the patient's vasculature and / or in other suitable situations. When the component of the atelectomy system 10 shown in FIG. 5 is rotated, an external load (eg, drag and / or torque application) acting on the component due to the curved portions 54, 56 of the component, and / or the configuration. Other bends in the element (eg, due to the winding or winding path of the patient's vasculature) are significant and can affect the load output of the motor 37 to the rotating device 20. In order to take into account the external load acting on the component of FIG. 5 when compared to the external load acting on the component of FIG. 4, the reference load output described above and described in more detail below is determined from the motor 37. It is used to take into account additional external loads by adjusting a predetermined range of load outputs, and can ensure that appropriate load outputs can be provided to the rotating device 20 to pass the blockage. Adjusting a predetermined range of load output from the motor 37 based on the reference load output may be acceptable without exceeding the "safety limit" of torque (eg, output load) in the patient's rotating device 20. This is because the external load acting on the components of the telectomy system 10 between the motor 37 and the rotating device 20 limits the load output supplied by the rotating device 20 and makes the load output on the rotating device 20 "safe". This is because it can be maintained below the "limit".

6 and 7 show when the component of the atherectomy system 10 is a nearly linear configuration with no bends or bends (eg, as shown in FIG. 4), and the component of the atherectomy system 10 (eg, FIG. FIG. 5 shows a graph describing the range of load output from the motor 37 required when in a curved or bent configuration (as shown in 5). 6 and 7 show a range of load outputs A from the motor 37 that can be safely used to pass the blockage when the components of the atherectomy system 10 are configured as shown in FIG. Here, the lower limit of the range A can be regarded as the reference load output, and the upper limit of the range A can be regarded as the maximum load output that can bring about the "safety limit" of the torque in the rotating device 20. The range B shown in FIGS. 6 and 7 shows the range of load output from the motor 37 that may be required to pass the blockage when the components of the atherectomy system 10 are configured as shown in FIG.

The load output from the motor 37 may be measured with one or more real-time motor parameters. Examples of real-time motor parameters include, but are not limited to, motor speed (eg, rpm), motor torque, drive current, drive voltage, drive power, and the like.

In FIGS. 6 and 7, range A and range B do not extend from the zero (0) load output, but range A and / or range B (eg, when the reference load output can be set to zero (0)). It is contemplated that it may have a minimum load output of zero (0) (and / or in other suitable circumstances). Further, FIGS. 6 and 7 show a shift of range A to reach range B (eg, shift or adjustment of both minimum load output and maximum load output), but of range A minimum load output or range A. It is contemplated that only one of the maximum load outputs can be adjusted to reach range B.

FIG. 6 shows range A and range B, where range A is a predetermined fixed range of possible load outputs from the motor 37 for passing through the blockage (eg, range A is the drive shaft 18). Can be predetermined while in the configuration shown in FIG. 4 and / or other suitable configuration). Range B allows the drive shaft 18 and the rotating device 20 to pass the occlusion in an appropriate manner by an external force acting on the driving shaft 18 and the rotating device 20 when the drive shaft 18 and the rotating device 20 are inserted into the patient's vasculature. The range of load output from the motor required for this. As shown in FIG. 6, when a predetermined range A of the load output from the motor 37 is a fixed range of the load output from the motor 37, the control system of the teletomy system 10 and the motor 37 are the load output from the motor 37. To ensure that the blockage is traversable in the desired manner, as the maximum amount (eg, represented by line 58) is represented by the maximum load output in range B (eg, line 60 in range B). Because it is set to a fixed value lower than the maximum load output from the motor 37 required for For example, range A and range B may overlap, but range A is a possible fixed load output from the motor 37, and the maximum value of range A is below the maximum value of range B ( (See, eg, difference 61 between line 58 and line 60), so the user (eg, a doctor or other user) uses the atelectomy system 10 to pass through the target occlusion without stopping or within the desired time range. When it may not be possible, the load output at the rotating device 10 may be insufficient to pass through the blockage, resulting in an increased risk of patient injury.

FIG. 7 shows a range A and a range B, and the range of possible load outputs from the motor 37 is variable. As shown in FIG. 7, when the range of possible load outputs from the motor 37 is variable, the control system of the telectomy system 10 and the motor 37 are subject to external forces due to bending, bending, and / or factors of the telectomy system 10. When acting on the components, load output from the appropriate motor 37 can be provided to ensure that the blockage is passable in the desired manner (eg, the need for range B). (Represented by line 58 representing maximum load output from motor 37 and line 60 having the same value) adjusted for line 58 in FIG. 6 to meet. In some cases, the difference 62 between the maximum load output in range A and the maximum load output in range B may be based on the reference load output, as discussed in more detail below.

FIG. 8 shows a method 100 for operating and / or controlling an atherectomy system (eg, an atherectomy system 10 or other suitable atherectomy system). In some cases, the method 100 for operating and / or controlling the atherectomy system is a rotating device (eg, rotating device 20 or other suitable rotating device) and a drive shaft (eg, drive shaft 18 or other) of the atherectomy system. A suitable drive shaft) can be incorporated into an atherrectomy procedure that is inserted into the patient's vasculature to a position within the blood vessel adjacent to the occlusion. To take into account the external load acting on the atherectomy system due to the tortuous nature of the patient's vasculature, Method 100 ensures that the rotating device is provided with the appropriate load to cross the occlusion. It can be performed to regulate the load output of a motor of an atherrectomy system (eg, motor 37 or other suitable motor).

Method 100 may include initiating rotation of the motor 102. In some cases, the drive shaft and rotating device of the atherectomy system is located adjacent to the occlusion through the patient's vasculature in off mode of the motor or without causing the motor to rotate the drive shaft 18 and / or the rotating device. Can be delivered to. Thus, when the rotating device reaches a location adjacent to the blockage, the motor goes into on mode (eg, start in response to a user or other control operation) and the motor rotates first.

When the motor is started and / or rotated for the first time, the load output from the motor (eg, the initial load output) can be determined 104. In some cases, if the rotating device of the atelectomy system is adjacent to the blockage but not yet engaged, the load output from the motor will be a sensor (eg, sensors 44, 46 and / or other suitable sensors). ) Is determined based on the feedback. Such determined load output from the motor may be set as a reference load output and stored in memory (eg, memory 40 or other suitable memory). In some cases, the determined load output from the motor can be compared to the expected load output and / or threshold load output from the motor to determine the reference load output, but this is not required.

When the motor is started and / or rotated for the first time, the value of the maximum load output from the motor can be determined 106. In some cases, the control system of the atherectomy system can set the value of the maximum load output from the motor to a value based on the determined load output from the motor. The value of the maximum load output from the motor is not limited to these, but shifting the load output in the predetermined range from the motor, adjusting the upper limit of the predetermined range of the load output from the motor, and the load output from the motor. It is set in one or more ways, including adjusting the lower bound of a predetermined range and / or setting the maximum load output of the motor in one or more other ways. Once set, the value of the motor's maximum load output may be stored in memory for access and / or other purposes by the processing unit (eg, processing unit 38 or other suitable processing unit).

In some cases, the maximum load output from the motor can be a function of or based on the reference load output of the motor. In such cases, the determined load output from the motor can be the reference output load of the motor, or the value of a function based on the determined load output of the motor.

By shifting the load output in a predetermined range, when the maximum load output from the motor is set to a value based on the reference load output from the motor, the load output in the predetermined range can be effectively shifted in various ways. .. In one example, a given value between a given minimum load output, a given maximum load output, and / or a given range of load outputs between the given minimum load output and the given maximum load output is based on the value of the reference load from the motor. Can be shifted. In one case, the reference load output from the motor is X and the predetermined range of load output is between Y (eg, the predetermined minimum load output from the motor) and Z (eg, the motor). The predetermined range of the load output adjusted in consideration of the load output can be a range between the values of Y + f (X) and Z + f (X). In some cases f (X) is equal to X, but this is not required. The values Y and Z can be predetermined values such that each of Y + f (X) and Z + f (X) is a predetermined value larger than the reference load output from the motor. Alternatively or additionally, only one of the minimum value of the load output in the predetermined range and the maximum value of the load output in the predetermined range may be adjusted.

In another example, if a given range of load output from the motor is a function of the reference load output from the motor, a tare function is executed and the reference load output from the motor is reset to zero (0). Set. When the tare function is executed, the control system of the atelectomy system uses the load output from the same predetermined range of motors, regardless of the reference load output from the motor, and instead the load output from the determined motor. And / or adjust the control signal value and / or other values based on the reference load output from the motor. When using the tare function to set the maximum load output from the motor, the maximum load output from the motor may be a predetermined value greater than zero (0) or some other value.

In some cases, the control system (including, for example, control 52 or other suitable control) automatically determines the load output from the motor and the motor after the motor has started and / or first rotated. Can be configured to set the maximum load output from. In one example, the control system can automatically determine the load output from the motor and set the maximum load output from the motor at a given timing after the motor has started and / or first rotated. Examples of predetermined timing are, but are not limited to, 0.5 seconds, 1 second, 2 seconds, 5 seconds, 10 seconds, and / or others after the start of the motor and / or after the first rotation of the motor. Including the appropriate time.

As mentioned above, the atherectomy system may include a selectable button (eg, button 27 or other suitable button), which initiates the determination of the load from the motor, after the motor has started and / or the motor. Can be selected or otherwise operated to set the maximum load output of the motor after the first rotation. In one example, if a button is included, the button is activated and one or more of the techniques described herein or other suitable techniques are used to initially set the maximum load output from the motor. Can be done. Additional or alternative, the button is maximally loaded from the motor at any suitable time during operation of the atherectomy system, using one or more of the techniques described herein or other suitable technique. Can be activated to set the output. In one example, the button may be activated first to start setting the maximum load output from the motor first and then actuated again to set the maximum load output from the motor a second time. Such examples can occur if the rotating device 20 and / or the drive shaft 18 is rearranged in the patient's vasculature during the procedure and / or in one or more other suitable examples. .. In a further example, the atherectomy system can be configured to automatically start initializing the maximum load output from the motor at the start of the motor and / or at the first rotation of the motor, followed by a button. It can be activated to set the maximum load output from the second motor. Buttons, when included in an atherectomy system, can be utilized to set the maximum load output from the motor in one or more suitable additional or alternative ways.

After setting the maximum load output from the motor 106, the atherectomy system can be configured to determine the control signal of the motor 108. The control signal is such that the load output from the motor is below the maximum load output from the set motor, yet external loads (eg, loads acting on drive shafts, rotating devices, long members, and / or load outputs from the motor). The techniques discussed herein are sufficient to provide sufficient load to the rotating device to pass the occlusion, even in view of the load acting on other components of the atelectomy system that affect the transmission of the It can be configured in any suitable way, including but not limited to. Once the control signal is determined 108, the control unit of the teletomy system outputs the control signal to the motor or other components of the teletomy system 110, sufficient for the load output from the motor to pass through the blockage. It controls the rotation of the motor and rotating device according to a control signal that ensures that it remains below the maximum load output from the configured motor.

FIG. 9 shows that the maximum load output of a set motor (eg, motor 37 or other suitable motor) of an atherrectomy system (eg, atherrectomy system 10 or other suitable atherrectomy system) is the safety limit of the output load from the motor. A method 200 for ensuring that the value is not exceeded is shown. The safety limits of the load output from the motor are not limited to these, but are limited to the configuration of the components of the atherectomy system such as the atherectomy procedure and the motor, the configuration of the drive shaft (eg, drive shaft 18 or other suitable drive). Shaft), rotation device configuration (eg, rotation device 20 or other suitable rotation device), catheter or sheath configuration (eg, length member 22 or other suitable length member), and / or teletomy system. It can be set based on various factors such as one or more other components.

In method 200, a value based on the load output of the motor can be determined 202. In some cases, the value 202 determined based on the load output of the motor is considered a reference value for the load output, but this is not required. The value determined based on the load output of the motor may be equal to the load output from the motor (eg, the determined or estimated load output from the motor as discussed herein) and / or the motor. It may be a function of the load output from. In some cases, the determined value based on the load output from the motor may be stored in memory (eg, memory 40 or other suitable memory).

After determining a value based on the load output from the motor, method 200 can include comparing the determined value with a threshold value 204. In some cases, the determined value may be a reference load output value and the threshold may be a threshold reference load output value.

The threshold may be associated with the "safety limit" load output value of the atherectomy system, similar to the "safety limit" value described above, but this is not required. In one use of the threshold, the threshold can be utilized and configured to facilitate ensuring that the load output on the rotating device does not exceed the safety limit.

When comparing the determined value to the threshold 204, the determination 206 determines whether the determined value reaches or exceeds the threshold, such as the control unit of the aterectomy system (eg, control unit 52 or other suitable control). Can be done by part). Alternatively, the user can make a decision in step 206 and enter the result of the comparison into the atherectomy system.

If the determined value has not reached or exceeded the threshold, the user or control unit of the atherectomy system can set the value of the maximum load output from the motor based on the determined value 208. In one example, the value of the maximum load output from the motor may be equal to the sum of a predetermined amount of load output from the motor (eg, the width of a predetermined range of acceptable load output from the motor) and the determined value. It may be well, or it may be equal to the value of a function of a predetermined amount of load output from the motor and a determined value. In some cases, the maximum load output from the motor is described how the maximum load output from the motor is determined based on a predetermined amount of load output from the motor and a determined value. It may be determined by a method similar to that of step 106 and / or other suitable method.

When the determined value reaches or exceeds the threshold, the user or control unit of the atherectomy system can set the value of the maximum load output from the motor based on the threshold 210. In one example, the value of the maximum load output from the motor may be equal to the sum of the predetermined amount of load output from the motor and the threshold, or equal to the value of a function of the predetermined amount of load output from the motor and the threshold. You may. In some cases, step 106 of Method 100 will explain how the maximum load output from the motor is determined based on a predetermined amount of load output and threshold from the motor. It may be determined in a manner similar to and / or in any other suitable manner.

Determined in step 208 and / or step 210, the value of the maximum load output from the motor may be stored in memory for access by the processing unit (eg, processing unit 38 or other processing unit). In some cases, the control unit of the atherectomy system obtains the maximum load output from the determined motor in a manner similar to that described above for steps 108 and 110 of method 100 and / or by any other suitable method. In consideration, the control signal of the motor can be determined and output.

Although not necessarily illustrated, the methods described herein (eg, methods 100, 200, and / or other methods) include one or more steps other than those described herein. The steps obtained and / or described may be performed in one or more other orders, as required, unless otherwise specified. In addition, the methods described herein may be repeated at the time of request or initiation, continuously, at predetermined intervals, and / or at other times during the operation of the atherectomy system 10.

Those skilled in the art will recognize that this disclosure may be manifested in various forms other than the particular embodiments described and contemplated herein. For example, as described herein, various embodiments include one or more modules described as performing different functions. However, other embodiments may include additional modules that divide the described functionality across more modules than those described herein. In addition, other embodiments can integrate the described functions into fewer modules.

Although various features have been described for, but not all, embodiments, the present disclosure contemplates that those features may be included in any embodiment. Moreover, although the embodiments described herein may omit some combinations of the various features described, this disclosure comprises any combination of the various features described. Is assumed. Therefore, changes in form and details can be made without departing from the scope and spirit of the present disclosure set forth in the appended claims.

Claims (10)

With the drive shaft,
With the rotating tip coupled to the first end of the drive shaft,
A motor coupled to the second end of the drive shaft and configured to rotate the rotary tip.
A control unit configured to control the output from the motor, and the control unit is
It is configured to determine the output from the motor after the first rotation of the motor and set the maximum output from the motor after the first rotation of the motor based on the determined output from the motor. An atelectomy system including the control unit. The control unit has an output from the motor in a predetermined range, and the control unit shifts the output in the predetermined range based on the determined output from the motor to set the maximum output from the motor. The atherectomy system according to claim 1 . The control unit is configured to set the maximum output from the motor to a predetermined value larger than the determined output from the motor, according to one of claims 1 and 2. The described ateletomy system . The control unit
The determined output from the motor is compared with the threshold value, and
If the determined output from the motor reaches or exceeds the threshold, the reference output from the motor is set to the threshold.
When the determined output from the motor does not reach the threshold value, the reference output from the motor is set to the output from the determined motor.
The atherectomy system according to any one of claims 1 to 3 , wherein the maximum output from the motor is set based on the reference output from the motor. The control unit is configured to set the reference output from the motor to zero and set the maximum output from the motor based on the reference output from the motor, according to any one of claims 1 to 4 . The atherectomy system described in any one of the items. With more buttons
The atherectomy system according to claim 5 , wherein the control unit is configured to set a reference output from the motor to zero when the button is activated. The atherectomy system according to claim 5 or 6 , wherein the control unit is configured to automatically set a reference output from the motor to zero at a predetermined timing after the first rotation of the motor. With more buttons
The atherectomy system according to any one of claims 5 to 7 , wherein the control unit is configured to set a maximum output from the motor when the button is activated. The invention according to any one of claims 1 to 8 , wherein the control unit is configured to automatically set the maximum output from the motor at a predetermined timing after the first rotation of the motor. Atherectomy system . With more buttons
The control unit sets the maximum output from the motor after the first rotation of the motor for the first time, and sets the maximum output from the motor after the first rotation of the motor for the second time in response to the operation of the button. The atelectomy system according to any one of claims 1 to 9 , wherein the second time is after the first time.

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